How long will it take to get approval to market my generic animal drug product?
The statutory limit for approval of an ANADA is 180 days, as it is for a New Animal Drug Application (NADA). Seldom, however, is an application approved on the first submission. When an incomplete letter is sent to an applicant, the 180-day clock restarts upon receipt of the applicant’s response. This process may continue, in some cases for several cycles. Generally, an ANADA will have a shorter average overall approval time than an NADA because of the relatively lesser complexity of the generic application. The time of approval, to a large extent, depends upon the quality and completeness of the original application and its subsequent amendments.
